Bivona 67HA70Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15021312013801), received between Apr 5, 2017 and Aug 10, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K081440); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193513 ↗
• MalfunctionJun 25, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE LEAKAGE WAS OBSERVED ON THE CUFF. THIS ISSUE MAY RESULT IN INADEQUATE VENTILATION TO THE PATIENT AND COULD POTENTIALLY LEAD TO SERIOUS INJURY. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25625767 ↗
• MalfunctionApr 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE FIRST TRACHEOSTOMY TUBE WAS PLACED AND FOUND LEAKAGE AFTER 4 DAYS OF USE. THEN THE SECOND ONE WAS PLACED AND FOUND LEAKAGE ON THE 1ST DAYS OF USE. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE HOSPITAL. THERE WAS NO DELAY IN THERAPY THAT WAS CRITICAL TO THIS PATIENT. THIS PROBLEM WAS SOLVED BY REPLACING WITH A NEW ONE. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791514 ↗
• MalfunctionApr 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER FOUR HOURS REPLACING THE DEVICE, THE RESIDUAL AMOUNT OF WATER IN THE CUFF WAS 1ML. THIS PROBLEM WAS RESOLVED BY REPLACING WITH ANOTHER BRAND PVC TRACHEOSTOMY TUBE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS UNKNOWN PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778499 ↗
• MalfunctionDec 12, 2024Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT LEAKAGE WAS FOUND ON THE INFLATION LINE DURING THE PRE-TEST. THIS PROBLEM WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW ONE. THE EVENT OCCURRED IN THE HOSPITAL AND THE OPERATOR WAS A HEALTH PROFESSIONAL. NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914252 ↗
• MalfunctionAug 14, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND WHEN THE TRACHEOSTOMY TUBE WAS IN USE WITH PATIENT ON THE 16TH DAY OF USE. THIS PROBLEM WAS SOLVED BY REPLACING WITH A NEW BIVONA 67HA70. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982589 ↗
• MalfunctionJun 13, 2023Defective Component; Defective Component

  IT WAS REPORTED, THAT THE DEVICE WAS FOUND WITHOUT A HOLE FOR SECURING THE LOCKING PIN. NO PATIENT HARM OR INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121104 ↗
• MalfunctionOct 13, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON OPENING THE PRODUCT, THE NURSE READ THE PRODUCT INSTRUCTION FOR USE (IFU) AND COMPARED THE ENGLISH TEXT TO THE FINNISH TEXT AND NOTICED THAT THE TRANSLATION WAS NOT CORRECT, OBSERVED WITH FOUR LOT NUMBERS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598099 ↗
• InjuryAug 19, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE RING WAS WELL TIGHTENED BUT IT WAS SLIPPING WHICH MADE THE TRACHEOSTOMY COME OUT. THE PATIENT HAS A PULMONARY PATHOLOGY THAT HAS LED TO A FAILURE OF INTUBATION AND THEREFORE TO AN EMERGENCY TRACHEOSTOMY. PATIENT HAD TO BE SEDATED OVER THE LONG TERM TO AVOID DECANULATION. HAVING A GRANULOMA IN THE TRACHEA, WHEN THE TRACHEOSTOMY CAME OUT, IT CAME UP AGAINST THE GRANULOMA PREVENTING ANY VENTILATION. PATIENT HAD SEVERAL FIBROSCOPIES TO URGENTLY PUT THE CANNULA BACK IN PLACE. THE CANNULA HAD TO BE MAINTAINED BY ADHESIVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pulmonary Dysfunction

  MAUDE report 15262625 ↗
• MalfunctionJan 5, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PILOT BALLOON WAS FOUND DETACHED AFTER 6 DAYS OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171396 ↗
• MalfunctionJan 15, 2021Leak/Splash

  INFORMATION WAS RECEIVED THAT DEVICE CUFF WAS FOUND LEAKING AFTER TWO DAYS IN USE. A SECOND CUFF WAS INSERTED AND AFTER TWO DAYS USE, THE CUFF LEAKED AGAIN. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11177036 ↗
• InjuryDec 30, 2020Leak/Splash; Leak/Splash

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT HYPERFLEX TTS TUBE LEAKED AFTER TWO DAYS IN USE. A SECOND CUFF WAS INSERTED AND AFTER TWO DAYS IN USE THE SECOND CUFF WAS INSERTED LEAKED AGAIN. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11098798 ↗
• MalfunctionApr 5, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY TUBE WAS IN PATIENT USE FOR ONE WEEK WHEN IT WAS OBSERVED THAT THE CUFF WAS BROKEN. THE REPORTED DEVICE WAS REPLACED. THE EVENT WAS OBSERVED SPONTANEOUSLY BY HOSPITAL PERSONNEL DURING THE INITIAL USE OF THE DEVICE. ACCORDING TO THE REPORT, THE CUFF PATENCY WAS TESTED PRIOR TO PATIENT USE AND THE CUFF WAS FILLED WITH STERILE WATER. NO ADVERSE EFFECT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6461865 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081440. One submission often covers many models, so check the product and lot details in each record.

• Z-2485-2020 · May 26, 2020 · Terminated
  Pediatric Adjustable Flange Tracheostomy Tube Cuffless